CTTI now offers a facilitated Quality by Design (QbD) Workshop designed to help study teams identify critical-to-quality (CTQ) factors and proactively manage risk during trial design, before protocol lock. Available onsite or virtually, the one-day workshop provides study teams with hands-on guidance from experienced CTTI staff using a real, upcoming study.

Prior to the workshop, team members complete structured pre-work to evaluate potential critical-to-quality (CTQ) factors. During the facilitated session, CTTI staff help participants reach consensus on the study's CTQs, identify key risks, and explore strategies to eliminate or mitigate those risks through trial design. Teams leave with documented CTQs and mitigation plans, as well as an internal champion equipped to apply the process independently in future studies.

The workshop is grounded in the CTQ framework originated by CTTI and reflected in ICH E8(R1). Through hands-on guidance from CTTI facilitators, participating teams can strengthen their approach to identifying CTQ factors and managing risk proportionately from the design stage, supporting alignment with the expectations of ICH E8(R1) and the finalized ICH E6(R3).

The workshop is available to CTTI member organizations at no cost and to non-member organizations for a fee. Organizations interested in learning more are encouraged to contact CTTI to discuss how the workshop could support an upcoming study.